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University of Nebraska Medical Center

White House overhauls rules for risky pathogen studies

Science New policies for gain-of-function and “dual-use” research will cover broader swath of experiments.

The White House is tightening federal oversight of so-called gain-of-function (GOF) studies that could enhance risky viruses in ways that increase their ability to cause a pandemic. It is also overhauling rules for a broader category of federally funded research on dangerous pathogens that is considered “dual use,” because the results could be used as bioweapons.

The new rules, spurred by the COVID-19 pandemic and concerns about U.S.-funded studies in Wuhan, China, that manipulated bat viruses distantly related to SARS-CoV-2, will expand the number of studies that must undergo special reviews. But the rules, released yesterday by the Office of Science and Technology Policy (OSTP), are narrower than a proposal floated last year that many scientists feared would complicate studies on low-risk pathogens such as cold viruses and herpesviruses.

Many researchers involved in the intense debate over how to regulate GOF studies funded by the National Institutes of Health (NIH) appear to be generally satisfied by the new policy. It is “a very big step forward,” says biosecurity expert Tom Inglesby of the Johns Hopkins Center for Health Security, who has called for tighter GOF rules. “Based on an early read, we think this strikes a good balance,” says Allen Segal, chief strategy and public affairs officer for the American Society for Microbiology, which had concerns about regulatory overreach.

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